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Physical ActivityMAINTAIN-IINCT02946060

The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II

A study testing Audiobooks and Tempo-pace synchronized playlists in people with Physical Activity, run by Toronto Rehabilitation Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Activity
What is being tested?
Audiobooks and Tempo-pace synchronized playlists
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
169 participants
Where
1 siteCanada
Study dates
Feb 2016to Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation
  • Patients must be at least 18 years of age
  • Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)

Who cannot join

  • Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues
  • Participants with significant communication impairments
  • Participants currently enrolled in another intervention study

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Cardiac Rehabilitation and Prevention Program

    Toronto, Ontario, M4G 2V6

Other trials in Canada

About this study

This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.

Read the detailed description

Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.

Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.

The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.

The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.

Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.

Being tested
Audiobooks, Tempo-pace synchronized playlists, Usual Care
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AudiobooksOther

    iPods with audiobooks

  • Tempo-pace synchronized playlistsOther

    Playlists with or without RAS

  • Usual CareOther

    iPods containing either a silent track or white noise

Study groups in NCT02946060
Study groupRoleWhat they receive
Usual CareSham comparatorParticipants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute. Participants will receive an iPod with a silent track or white noise.
Receives: Other: Usual Care
AudiobooksActive comparatorParticipants in this arm will receive iPods with Audiobooks based on their preferred genres.
Receives: Other: Audiobooks
Tempo-pace Synchronized PlaylistsExperimentalParticipants in this arm will receive audio playlists synchronized to their exercise pace. Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study.
Receives: Other: Tempo-pace synchronized playlists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average volume of physical activity per week per intervention

    The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.

    Measured: 12 weeks

Secondary outcomes (9)
  1. Affect measured by Feeling Scale

    During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.

    Measured: Biweekly for the duration of 12 weeks

  2. Arousal measured by Score on Felt Arousal

    During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap

    Measured: Biweekly for the duration of 12 weeks

  3. Perceived Exertion measured by Rate of Perceived Exertion Scale

    During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.

    Measured: Biweekly for the duration of 12 weeks

  4. Dissociative Attention measured by the Tammen's Scale

    During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.

    Measured: Biweekly for the duration of 12 weeks

  5. Focus measured by the Focus Questionnaire

    During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.

    Measured: Biweekly for the duration of 12 weeks

  6. Pacing of Exercise

    Number of steps in one minute will be counted during exercise session.

    Measured: Biweekly for the duration of 12 weeks

  7. Lap time

    Time taken to complete one lap will be recorded for each biweekly exercise session.

    Measured: Biweekly for the duration of 12 weeks

  8. Playcounts

    Number of plays of the audio file per week will be recorded

    Measured: 8 week duration

  9. Future Hospitalizations and/or Mortality

    Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.

    Measured: Within 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionFeb 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946060
Sponsor's protocol ID
15-9839
Acronym
MAINTAIN-II
Status last verified
Apr 2020
First submitted
19 Sep 2016
Last updated
20 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Alter DA, Wijeysundera HC, Franklin B, Austin PC, Chong A, Oh PI, Tu JV, Stukel TA. Obesity, lifestyle risk-factors, and health service outcomes among healthy middle-aged adults in Canada. BMC Health Serv Res. 2012 Aug 4;12:238. doi: 10.1186/1472-6963-12-238.

    PubMed 22863333
  • Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.

    PubMed 25079239
  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PubMed 7154893
  • Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.

  • Brownley KA, McMurray RG, Hackney AC. Effects of music on physiological and affective responses to graded treadmill exercise in trained and untrained runners. Int J Psychophysiol. 1995 Apr;19(3):193-201. doi: 10.1016/0167-8760(95)00007-f.

    PubMed 7558986
  • Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.

    PubMed 16777432
  • Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.

    PubMed 20614453
  • Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.

    PubMed 21576654
  • Hardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317

  • Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.

    PubMed 21735386
  • Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.

  • Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.

    PubMed 20209028
  • Nakamura PM, Pereira G, Papini CB, Nakamura FY, Kokubun E. Effects of preferred and nonpreferred music on continuous cycling exercise performance. Percept Mot Skills. 2010 Feb;110(1):257-64. doi: 10.2466/PMS.110.1.257-264.

    PubMed 20391890
  • Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.

    PubMed 18525377
  • Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.

Questions about this trial

What is this clinical trial studying?

A study testing Audiobooks and Tempo-pace synchronized playlists in people with Physical Activity, run by Toronto Rehabilitation Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average volume of physical activity per week per intervention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02946060, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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